The Food and Drug Administration (FDA) has granted Orphan Drug designation to TNP-2092 (TenNor Therapeutics) powder for intravenous (IV) injection for the treatment of prosthetic joint infections.
Prosthetic joint infection is a complication of hip or knee arthroplasties that often requires a prolonged course of antimicrobials and surgical intervention due to the formation of bacterial biofilms. TNP-2092 is a first-in-class multitargeting drug conjugate that specifically inhibits 3 essential targets in bacterial biofilms: RNA polymerase, DNA gyrase and topoisomerase IV.
The designation was based on data from in vitro and in vivo models that showed TNP-2092 had potent bactericidal activity against major pathogens associated with bacterial biofilms, a low potential for developmental resistance and an excellent safety profile. The efficacy of TNP-2092 was also found to be superior to the current standard of care against bacterial biofilms in animal models.
In addition, the Company has reported positive topline data from the phase 2 trial (P2_ABSSI) of TNP-2092 IV for the treatment of acute bacterial skin and skin structure infection. An oral formulation of TNP-2092 is also currently being investigated for the treatment of diseases associated with gastrointestinal infections.
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